ADEA Washington Update

Revised Rule on Human Subjects in Research Effective January 2019

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CommonRuleMost dental schools have a Dental Research Administration (DRA) to promote and assist students, residents and faculty on how to properly develop and conduct research studies at the schools. The DRA helps researchers work through the requirements of the school’s Institutional Review Board (IRB). Last year, the Department of Health and Human Services (HHS), along with 15 other federal agencies revised, the protections for research study and clinical trial participants for the first time in nearly 30 years. The Federal Policy for the Protection of Human Subjects, referred to as the Common Rule, was supposed to take effect this summer but was delayed, in part, until Jan. 21, 2019. 

In the meantime, dental institutions have the option to implement for certain research three provisions of the 2018 requirements. The three provisions are (1) The revised definition of ”research,” which deems certain activities not to be research covered by the Common Rule; (2) the elimination of the requirement for annual continuing review with respect to certain categories of research; and (3) the elimination of the requirement that IRBs review grant applications or other funding proposals related to the research. Dental institutions that conduct human research will have substantial work in educating researchers and advisors. Some of the required changes will rely upon guidance and updates that the Office for Human Research Protections has yet to provide, such as guidance on consent.

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